Orteronel Plus Prednisone Fails to Improve Survival in Metastatic Castration-Resistant Prostate Cancer
the Cancer Therapy Advisor take:
According to a new study published in the journal The Lancet Oncology, researchers have found that the combination of orteronel and prednisone improved progression-free survival, but not overall survival, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) compared with placebo plus prednisone.
For this double-blind, placebo-controlled, phase 3 study, researchers enrolled 1,560 patients with chemotherapy-naive mCRPC and randomly assigned them 1:1 to receive either orteronel 400mg plus prednisone 5mg twice daily or placebo plus prednisone 5mg twice daily.
Results showed that with a median follow-up of 8.4 months, the median radiographic progression-free survival was 13.8 months (95% CI: 13.1 - 14.9) and 8.7 months (8.3 - 10.9) with orteronel and prednisone, respectively (HR = 0.71; 95% CI: 0.63 - 0.80; P < 0.0001). In addition, with a median follow-up of 20.7 months, the median overall survival was 31.4 months (95% CI: 28.6 - NE) with orteronel compared with 29.5 months (27.0 - NE) with placebo (HR = 0.92; 95% CI: 0.79 - 1.08; P = 0.31).
Orteronel plus prednisone was also associated with increased toxicity versus placebo prednisone. The negative findings have led to the discontinuation of development of orteronel for mCRPC.
Combination orteronel and prednisone did not improve overall survival in mCRPC.
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- Metastatic Prostate Cancer Responds to Novel Radiation Therapy
- Clinical Applications of Liquid Biopsies in Cancer
- Two-Drug Combination Superior to Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
- Radical Prostatectomy Compared With Watchful Waiting in Localized Prostate Cancer
- Immunotherapy in Glioblastoma: Peaks and Pits
- OS and PFS End Points Not Met in Phase 3 Trial of Pembrolizumab in Advanced HCC
- No Benefit Observed With Osimertinib Plus Durvalumab in EGFR-Mutated NSCLC
- Evidence of the Role of Circulating Insulin on Renal Cell Carcinoma Risk
- Treatment Guidelines in Cancer: Assessing Industry Influence on Recommendations
- American Society of Breast Surgeons Recommends Genetic Testing for All Patients With Breast Cancer